This invention relates to suturing devices and suturing methods.
Health practitioners frequently use sutures to close various openings such as cuts, punctures, and incisions in various places in the human body. Because of their importance and frequent use, several types of sutures and devices for their implantation and extraction have been developed. These devices include needles having various shapes and sizes as well as devices for inserting and removing staples. Generally, sutures are convenient to use and function properly to hold openings in biological tissue closed thereby aiding in blood clotting, healing, and prevention of scaring. There are however some circumstances under which it is not feasible to use conventional sutures and suturing methods to close an opening. Some of these circumstances occur with incisions in arterial walls.
The arteries are the blood vessels which carry blood to the various body cells from the heart, and compared to veins, which carry blood back to the heart, the blood pressure in arteries is significantly higher. A typical blood pressure in the veins is 30 mmHg. A typical arterial blood pressure measurement is 120 over 80 mmHg. The higher reading, 120 mmHg, represents the systolic pressure which occurs when the ventricles of the heart contract forcing blood into the arteries, and the lower reading, 80 mmHg, represents the diasystolic pressure when the ventricles of the heart are relaxed and refilling with blood.
During a typical arterial catheterization procedure, which can be performed in a hospital or catheterization lab, a relatively small incision is made in the upper thigh and then in the femoral artery. A catheter is inserted through the incision and directed along an arterial path to a target area such as the heart for performance of any number of many possible procedures such as angioplasty and angiograms. Upon completion of the catheterization procedure, closure of the arterial incision is problematic because of the relatively high blood pressure in the arteries and because the small incision made in the thigh does not provide enough working space for a health practitioner to suture the artery in a conventional manner with hemostats and conventional suturing needles.
To close the incision in the femoral artery and prevent significant blood loss, the catheter is removed, and a health practitioner applies direct pressure to the leg for twenty minutes carefully monitoring the femoral pulse to assure that the applied pressure is not compressing the artery to the point of blockage (occlusion). The health practitioner applies the pressure immediately after the procedure because the artery must not be occluded or severe injury could result to the leg. After twenty minutes, the health practitioner will give this responsibility to another person typically a nurse who will continue to monitor the application of direct pressure for an extended period of time typically beyond twenty-four(24) hours.
Because it is not possible for medical personnel to personally apply direct pressure for such a long time, several devices have been developed to aide in application of direct pressure to the thigh. These devices include large clamps, sand bags and others, yet because of the high blood pressure in the artery, the blood clots on the artery frequently rupture while the direct pressure devices are applied or after direct pressure is removed. If a blood clot ruptures and is not restored, the patient may bleed to death. Because blood clots on the artery frequently rupture and because of the possible severe consequences of a ruptured blood clot, patients are held overnight in the hospital or catheterization lab for observation to assure that the blood clots do not rupture. Thus, these types of procedures are performed on an inpatient basis, so that the patient is observed long enough after the procedure to assure that the clot is permanently established and the femoral artery is not bleeding.
If during the observational period the direct pressure repeatedly fails to close the vessel, a health practitioner may have to operate on the patient. During this operation, the patient is anesthetized, the blood flow to the artery is occluded, an incision is made in the upper thigh to allow enough room for conventional suturing with a needle, the artery is sutured, the blood flow restored, and the incision in the thigh is sutured. This obviously results in additional discomfort to the patient, a longer hospital stay, and increased expense.
Thus, reducing the time which direct pressure must be applied to an arterial opening, the frequency with which blood clots on arteries rupture, the time which must be spent in the hospital or catheter lab, and the frequency of operations are desirable to reduce medical costs and patient discomfort.